New Drug Application definition

New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the US.

New Drug Application means a new drug application filed with the FDA pursuant to 21 C.F.R. §314, seeking permission to market the Product for a particular Indication in the Field in interstate commerce in the United States.

Examples of New Drug Application in a sentence

• All records for the Study shall be retained for the following period of time: (1) two (2) years after the FDA approves the New Drug Application (NDA) Premarket Approval Application (PMA); (2) two (2) years following the termination or withdrawal of the health regulatory agency exemption (e.g., Investigational New Drug (IND) application) under which the Study is being conducted; or 7.

• Letterhead] May 8, 2024 [***] [***] Re: Xolremdi (mavorixafor) capsules NDA 218709, SN:[●] Transfer of Rare Pediatric Disease Priority Review Voucher PRV NDA 218709 Dear [***]: Reference is made to the New Drug Application (NDA) 218709 approval letter dated April 26, 2024 (the “Approval Letter”) (Ref ID: 5371673) reflecting the grant of the Rare Pediatric Disease Priority Review Voucher PRV NDA 218709 (the “Voucher”) to X4 Pharmaceuticals, Inc.

• Všechny záznamy ze Studie je třeba uchovávat po následující období: (1) dva (2) roky poté, co FDA schválí žádost o registraci nového léku (NDA, New Drug Application) v režimu PMA (Premarket Approval Application); (2) dva (2) roky po ukončení nebo odvolání výjimky udělené zdravotním kontrolním orgánem (např.

• If submission of a New Drug Application was developed or submitted by any sublicensee 10% Sublicensing Revenue will be due.

• For greater certainty a Milestone Payment shall be due and payable by the Licensee on submission of a New Drug Application for each Product if developed or submitted by the Licensee.

More Definitions of New Drug Application

New Drug Application or "NDA" means (a) the single application or set of applications for Products and/or pre-market approval to make and sell commercially both a formulation of Compound and a compatible commercial Device to be marketed as Product, filed by Lilly with the appropriate regulatory authority within the Territory, and (b) any related registrations with or notifications to the appropriate regulatory authority within the Territory. This term does not include any of Lilly's Regulatory Approvals in the Territory for any insulin products other than the Products contemplated in this Agreement.

New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

New Drug Application or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.

New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the U.S.

New Drug Application means a new drug application, submitted to the FDA under 21 U.S.C. § 355(b) for authorization to market a drug in the United States.

New Drug Application or “NDA” shall mean an application submitted pursuant to FDCA Section 505(b) and described in 21 C.F.R §310.50, and amendments and supplements thereto.

New Drug Application means a new drug application filed with the FDA under 21 U.S.C. § 355(b).